Perforator Handpiece 1700761-001

GUDID 17630055506518

Bien-Air Surgery SA

Manual cranial rotary handpiece, reusable
Primary Device ID17630055506518
NIH Device Record Keyabb0a426-737d-4f49-8d42-118cb08dd594
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerforator Handpiece
Version Model Number362640
Catalog Number1700761-001
Company DUNS481597719
Company NameBien-Air Surgery SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117630055506518 [Primary]

FDA Product Code

HBCMotor, Drill, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-27
Device Publish Date2023-03-17

Devices Manufactured by Bien-Air Surgery SA

17630055513752 - Bur PM2-150 80K Steel Ø4.0 St2024-12-12
17630055513769 - Bur PM2-150 80K Steel Ø3.1 St2024-12-12
17630055513783 - Bur PM2 80K Steel TD Ø1.1x5 St2024-12-12
17630055513790 - Bur PM2 80K Steel TD Ø1.1x4 St2024-12-12
17630055513813 - Bur Cranial Straight 25 mm St2024-12-12
17630055513820 - Bur Cranial Spiral 25mm St2024-12-12
17630055513837 - Bur Cranial Spiral 10mm St2024-12-12
17630055513844 - Bur Cranial Straight 10mm St2024-12-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.